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Serving leading biopharmaceutical companies globally:

Citi
Medtronic
Harvard Business School
Argus Health
Farmers Insurance
Chubb
Accenture
UBS
Moodys
Cipla

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206793

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NDA 206793 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Actavis Mid Atlantic, Allied Pharma Inc, Amneal Pharms, Apotex Inc, Aurobindo Pharma, Bio Pharm Inc, Cypress Pharm, Perrigo R And D, Ranbaxy Labs Ltd, Silarx, Taro, Tris Pharma Inc, Jubilant Generics, Novel Labs Inc, Sandoz, and Sun Pharma Global, and is included in eighteen NDAs. It is available from sixty-three suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY profile page.

The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-seven suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 206793
Tradename:CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
Applicant:Novel Labs Inc
Ingredient:cetirizine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 206793
Suppliers and Packaging for NDA: 206793
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 206793 ANDA Novel Laboratories, Inc. 40032-652 40032-652-30 3 BLISTER PACK in 1 CARTON (40032-652-30) > 10 TABLET, CHEWABLE in 1 BLISTER PACK
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride TABLET, CHEWABLE;ORAL 206793 ANDA Novel Laboratories, Inc. 40032-652 40032-652-10 1000 TABLET, CHEWABLE in 1 BOTTLE (40032-652-10)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Mar 8, 2016TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength10MG
Approval Date:Mar 8, 2016TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
AstraZeneca
Covington
Novartis
Cipla
Boehringer Ingelheim
US Department of Justice
Chubb
Cerilliant

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